JP6936730B2 - 医療用包帯 - Google Patents
医療用包帯 Download PDFInfo
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- JP6936730B2 JP6936730B2 JP2017513542A JP2017513542A JP6936730B2 JP 6936730 B2 JP6936730 B2 JP 6936730B2 JP 2017513542 A JP2017513542 A JP 2017513542A JP 2017513542 A JP2017513542 A JP 2017513542A JP 6936730 B2 JP6936730 B2 JP 6936730B2
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Description
第1の化合物を含む接着層を設けること;および、
前記接着層に第2の化合物を含むコーティングを設けること;を含む、医療用包帯を製造する方法により達成される。
第1の化合物を含む接着層3を設けること;および
接着層3に第2の化合物を含むコーティング9を設けること;
にも関する。
使用材料:
Wackerから市販されているWacker SilGel (登録商標) 612 シリコーンベース接着剤(室温加硫シリコーン;2成分系)、Alfa Aesar から市販されている硫酸銀(Ag2SO4)、Akzo Nobel からのCMC、Epurexから市販されている約25μmの厚さであるポリウレタンフィルム。
43.3 gのSilgel 612 パートBを11.1 gのCMCと徹底的に混合した。均一混合物を得た後に、45.6 gのSilgel 612 パートAを添加し、そしてブレンドを徹底的に混合した。約11 %のCMCを含む混合シリコーンをポリウレタンフィルム上にコート質量60 gsmでコーティングし、そして145℃で5分間硬化した。冷却後に、硫酸銀の水溶液 (7.0 g/L)を調製し、そして次いで、硬化したシリコーン層の上に、実質的に均一に噴霧し(任意の適切な被覆装置または例えば、噴霧缶を使用)、そしてサンプルを室温にて少なくとも24時間乾燥した。噴霧された合計量は16.4 μL/cm2 であり、シリコーン層上の硫酸銀の合計量約115 μg/ cm2をもたらした。
42.4 gのSilgel 612 パートBを1.91 gの硫酸銀および11.1 gのCMCと徹底的に混合した。均一混合物を得た後に、44.6 gのSilgel 612 パートAを添加し、そしてブレンドを徹底的に混合した。1.91 %の硫酸銀および11.1%のCMCを含む混合シリコーンをポリウレタンフィルム上にコート質量60 gsmでコーティングし、そして145℃で5分間硬化した。シリコーンコーティングされたフィルムの銀濃度は約115 μg/ cm2であった。
42.6 gの Silgel 612 パートBを1.59 g の硫酸銀および11.0 gのCMCと徹底的に混合した。均一混合物を得た後に、44.8 gのSilgel 612 パートAを添加し、そしてブレンドを徹底的に混合した。1.59 %の硫酸銀および11 %のCMCを含む混合シリコーンをポリウレタンフィルム上にコート質量60 gsmでコーティングし、そして145℃で5分間硬化した。シリコーンコーティングされたフィルムは約95μg/cm2の濃度で銀を受けた。冷却後に、硫酸銀の水溶液(2.67 g/L)を調製し、次いで、硬化したシリコーン層の上に、実質的に均一に噴霧し(任意の適切な被覆装置または例えば、噴霧缶を使用)、そしてサンプルを室温にて少なくとも24時間乾燥した。噴霧された合計量は7.5 μL/cm2であり、シリコーン層上に硫酸銀の合計量約20μg/cm2をもたらし、これにより、最終製品中に硫酸銀の合計量約115 μg/ cm2をもたらした。
銀の放出は振とう法を使用することより決定した。原則的に、試験材料を試験媒体中に特定の時間、特定の温度で浸漬させた。その後、試験材料を試験媒体から取り出し、そして新鮮な試験媒体を含む別のウエルに浸漬させ、そしてさらに特定の時間だけ更にインキュベートした。この手順をさらなる回数繰り返した。試験材料に暴露されている試験媒体中の銀濃度は酸消化、次いで、誘導結合型プラズマ光学発光分光法(ICP-OES)による分析により決定した。
実施例1〜3の円形ピース(φ 28 mm)を3つ重ねで打ち抜き、そして2 mlの水中10% 普通ブロス(NB)を含む6-ウエルプレートの別々のウエルに入れた。6-ウエルプレートを35℃±2℃および100 rpm ± 5rpmで2時間インキュベートした。インキュベーションの後に、実施例1〜3の円形ピースを、新鮮10%NBを含む、6-ウエルプレートの新しいウエルに移動した。新しい6-ウエルプレートを35℃±2℃および100 rpm ± 5rpmでさらに 4時間 (合計6時間)インキュベートした。この手順をさらに2回、それぞれ18時間(合計で24時間)及び24時間 (合計で48時間)、繰り返した。
各測定点についての実施例1〜3の銀の放出量を図2に示す。試験の最後(48時間)に放出された銀の合計量を表1に示す。値は3つのサンプルの平均である。
Claims (10)
- 医療用包帯を皮膚表面に接着させるための皮膚対向面を有する接着層を備える該医療用包帯であって、前記接着層は第1の化合物を該接着層の内部に組み込んで含み、前記皮膚対向面の少なくとも一部は第2の化合物を含むコーティングを備え、前記第1の化合物と前記第2の化合物は同じであっても異なっていてもよい銀塩であり、
前記医療用包帯は、前記接着層に面する第1の表面を有する基材を更に備え、前記接着層の前記皮膚対向面は、前記基材の第1の表面から反対の方向に面しており、
前記接着層は、前記基材の第1の表面の少なくとも一部におけるコーティングであり、そして
前記第1の化合物の濃度は50〜2000μg/cm2であり、前記第2の化合物の濃度は1〜150μg/cm2であり、前記第1の化合物の濃度は前記第2の化合物の濃度よりも高い、前記医療用包帯。 - 前記接着層はシリコーン系接着剤を含む、請求項1に記載の医療用包帯。
- 前記医療用包帯は、前記基材の第1の表面と前記接着層の間に挟まれた有孔フィルム層を更に備え、前記接着層は、前記有孔フィルム層の無孔部分におけるコーティングである、請求項1又は2に記載の医療用包帯。
- 前記基材は吸収性材料を含む、請求項1〜3のいずれか1項に記載の医療用包帯。
- 前記吸収性材料は、親水性ポリウレタン発泡体などのポリマー発泡体、不織材料、繊維状親水性ポリマー材料といった繊維状材料、ゲル形成繊維、ハイドロゲル、ハイドロコロイドを含有するマトリックス、織り繊維および編み繊維からなる群から選択される、請求項4に記載の医療用包帯。
- 前記基材は、ポリウレタンフィルムといったポリマーフィルムである、請求項1〜3のいずれか1項に記載の医療用包帯。
- 前記基材は第3の化合物を含み、該第3の化合物は、前記第1の化合物および/または前記第2の化合物と同一である、請求項1〜6のいずれか1項に記載の医療用包帯。
- 前記第2の化合物を含む前記コーティングは、使用の際、創傷および/または周囲の皮膚表面と直接接触する意図である、請求項1〜7のいずれか1項に記載の医療用包帯。
- 前記第1の化合物および/または前記第2の化合物は抗菌性化合物である、請求項1〜8のいずれか1項に記載の医療用包帯。
- 医療用包帯を製造する方法であって、該方法は以下の工程:
基材の第1の表面の少なくとも一部へのコーティングにより接着層を設けること、ここで、該接着層は第1の化合物を前記接着層の内部に組み込んで含み、医療用包帯を皮膚表面に接着させるための皮膚対向面を有し、該皮膚対向面は前記基材の第1の表面とは反対の方向に面している;および、
前記接着層の皮膚対向面の少なくとも一部に第2の化合物を含むコーティングを設けること;を含み、
前記第1の化合物と前記第2の化合物は同じであっても異なっていてもよい銀塩であり、
前記第1の化合物の濃度は50〜2000μg/cm2であり、前記第2の化合物の濃度は1〜150μg/cm2であり、前記第1の化合物の濃度は前記第2の化合物の濃度よりも高い、前記方法。
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